Different Lugol's Solution Concentration for Image Quality of Esophageal Lesions in Chromoendoscopy With Iodine Staining

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Image Quality of Early Esophageal Squamous Neoplasia; Endoscopists'Subjective Assessments

Treatments: Drug: 0.4% Lugol's solution; Drug: 1.2% Lugol's solution; Drug: 1.0% Lugol's solution; Drug: 0.6% Lugol's solution; Drug: 0.8% Lugol's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03180970

2017SDU-QILU-G002

Details and patient eligibility

About

The purpose of this study is to assess whether lower Lugol's solution concentration can perceive the same image quality of early esophageal squamous neoplasia.

Full description

Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, this modality may cause severe chest pain and discomfort owing to mucosal irritation.

This study was to test whether a lower concentration of Lugol's solution can provide satisfied image quality of early esophageal squamous neoplasia and has lower mucosal irritation.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with early esophageal squamous neoplasia who underwent endoscopic submucosal dissection.

Exclusion criteria

After esophageal surgery or endoscopic treatment ; Known esophageal radiotherapy or chemotherapy ; Esophageal stenosis; Acute bleeding; A known allergy to iodine; Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds); Having food retention; Severe hepatic ,renal, cardiovascular or metabolic dysfunction ; Being pregnant or lactating.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 5 patient groups

group 1

Experimental group

Description:

This group patients were given dosages of 1.2% Lugol's solution for chromoendoscopy.

Treatment:

Drug: 1.2% Lugol's solution

group 2

Experimental group

Description:

This group patients were given dosages of 1.0% Lugol's solution for chromoendoscopy.

Treatment:

Drug: 1.0% Lugol's solution

group 3

Experimental group

Description:

This group patients were given dosages of 0.8% Lugol's solution for chromoendoscopy.

Treatment:

Drug: 0.8% Lugol's solution

group 4

Experimental group

Description:

This group patients were given dosages of 0.6% Lugol's solution for chromoendoscopy.

Treatment:

Drug: 0.6% Lugol's solution

group 5

Experimental group

Description:

This group patients were given dosages of 0.4% Lugol's solution for chromoendoscopy.

Treatment:

Drug: 0.4% Lugol's solution